EP3332718B1

EP3332718B1 - Cranial drill system

Info

Publication number: EP3332718B1
Application number: EP17202504.1A
Authority: EP
Inventors: Streatfield Gill Steven; Catriona FENNELLY
Original assignee: Renishaw PLC
Current assignee: Renishaw PLC
Priority date: 2012-06-01
Filing date: 2013-05-31
Publication date: 2024-02-14
Anticipated expiration: 2033-05-31
Also published as: CN107019543A; JP2015518751A; JP2019069157A; CA2874792A1; EP2854660A1; US10363049B2; CN104411258B; WO2013179053A1; CN104411258A; US20150127040A1; EP3332718A2; GB201209772D0; CN107019543B; JP6983745B2; US20190321056A1; EP3332718A3; CA2874792C; EP2854660B1; JP6475160B2; ES2974668T3

Description

Field of Invention

This invention concerns a kit comprising a cranial drill system for forming an opening in the skull and the brain. The invention has particular application to a cranial drill system for forming an opening in the skull suitable for receiving a cranial port, such as a cranial port connected with a device, such as a guide device, catheter or electrode.

Background

There are many situations where there is a requirement to deliver therapeutic agents to specific targets within the brain parenchyma via implanted catheters. Furthermore, many of these therapeutic agents will cause unwanted side effects if delivered to healthy parts of the brain. Examples of treating abnormalities of brain function include the acute infusion of Gamma-amino-buturic-acid agonists into an epileptic focus or pathway to block transmission, and the chronic delivery of opiates or other analgesics to the peri-aqueductal grey matter or to thalamic targets for the treatment of intractable pain. Also, cytotoxic agents can be delivered directly into a brain tumour. Intraparenchymal infusion can also be used to deliver therapeutic agents to brain targets that cannot be delivered systemically because they will not cross the blood-brain barrier. For example, the treatment of patients with Parkinson's disease, Alzheimer's disease, head injury, stroke and multiple sclerosis may be carried out by the infusion of neurotrophic factors to protect and repair failing or damaged nerve cells. Neurotrophins may also be infused to support neural grafts transplanted into damaged or malfunctioning areas of the brain in order to restore function.
It is also known to insert instruments other than catheters, such as electrodes, directly in the brain parenchyma. For example, stimulating and lesioning electrodes are used in a variety of surgical procedures, including deep brain stimulation (DBS) electrodes. A surgeon wishing to stimulate or lesion a particular area of nervous tissue can target the end of an electrode to the target site so that a desired electrical current can be delivered.
The above described methods rely on targeting the required site as accurately as possible. Slight misplacement of the instrument being inserted may lead to significant morbidity or treatment failure. For example, brain targets for treating functional disorders are usually deeply situated and have small volumes. A desired target for treating Parkinson's disease is situated in the sub-thalamic nucleus and is 3-4mm in diameter, or an ovoid of 3-4mm in diameter and 5-6mm in length. Other targets such as the globus palladus or targets in the thalamus are usually no more than 1-2mm larger. For such a small target sub-optimal placement of as little as 1mm will not only reduce the effectiveness of the treatment, but may also induce unwanted side effects such as weakness, altered sensation, worsened speech and double vision. It is also desirable to minimise trauma in certain regions of the brain; for example, the mesencephalon (which includes the subthalamic nucleus, the substantia nigra and the pedunculor-pontine nucleus) is a critical region of the brain where is it is important to minimise trauma from the passage of an electrode or catheter.
A variety of stereotactic devices and methods have thus been developed previously in an attempt to allow instruments to be accurately guided towards a target identified by a surgeon (e.g. using x-rays or magnetic resonance imaging) with the minimum of trauma to other regions of the brain. Examples of prior systems are given in EP1509153 , US6609020 and US6328748 .
GB2357700 discloses a guide device comprising a port (head) which is secured in a hole formed in the skull with a tube of the guide device extending into the brain. In order to insert the guide device into the skull a hole is first drilled into the skull under the guidance of a stereotactic frame. Often, the port has a larger diameter than the catheter/electrode/guide tube to be inserted into the brain. Therefore, it is desirable to drill an opening having a stepped form with an enlarged diameter portion for receiving the port. Devices for drilling such a stepped form are known, for example as described in WO2011/110874 .
To insert the guide device to the desired target the dura is perforated. The surgeon may do this with a scalpel or a device such as described in WO2009/047494 .
Use of a scalpel or a spike, such as disclosed in WO2011/110874 , to puncture the dura and the later insertion of probes, such as guide rods, guide tubes, catheters, in to the brain, especially through the denser parts of the brain, may result in the brain being displaced from its original position, resulting in the probes missing the target.
Furthermore, during formation of the openings in the skull and in the dura using these separate instruments, the openings may not be correctly located relative to each other. This is even the case if a stereotactic frame is used for positioning the instruments during formation of the openings as play in the stereotactic frame can result in errors in positioning. This may hinder insertion of an implantable instrument, such as a catheter with integrated port.
US2007/093841 A1 discloses a surgical drill and a system for removing bone in spinal surgery. The surgical drill and system are used in tasks to free up the spinal cord of matter that does not belong there.
EP1402843 A1 discloses a drill set for adjusting an implant hole for a self-tap dental screw implant fixture.

Summary of Invention

According to a first aspect of the invention there is provided a kit according to claim 1.
The cranial drill system may comprise one or more surgical drill elements for drilling into the brain.
Drilling out an opening in the brain may reduce the extent to which the brain is pushed away during penetration of the dura and during later insertion of probes, such as guide rods, guide tubes, catheters, electrodes etc, in to the brain. This may result in more accurate placement of the probes/implantable instruments.
The first and second drill elements may be arranged to cooperate together to define a relative position of openings formed using the first and second drill elements. The openings may include an opening in the skull and an opening in the brain. The drill elements may be arranged such that the openings are formed substantially concentric to each other.
The cranial drilling system may comprise a first drilling element for drilling into the brain and a second drilling element for drilling into the skull, the second drilling element having at least a portion with a diameter greater than a diameter of the first drill element. In this way, the drilling system can be used both for drilling an opening into the brain and for drilling an opening into the skull for holding an implantable instrument.
The second drilling element for drilling into the skull may comprises a profile that forms an opening in the skull having a narrower diameter portion and a wider diameter portion,
The second drill element may comprise a profile to form an opening in the skull with one, two or more stepped transitions between the narrower and wider diameter portions. In this way, the opening can support a correspondingly shaped part of an implantable instrument, such as a port of a catheter or guide tube.
The cranial drill system may comprise a mount for connecting the first and/or second drill elements to a coordinate positioning apparatus, such as a stereotactic frame and/or robot.
The first drill element may have a length sufficient to extend into the pia mater of the brain. The first drill element may have a length of greater than 10mm. In this way, the drill element may have sufficient length to reach targets in the brain. The drill element may comprise a twist drill, which may comprise two flutes.
A point angle of a tip of the first drill element may be less than 90°, less than 80°, less than 70° and preferably about 60°. It is believed that a sharp tip will aid penetration of the skull and dura reducing the chances of deflection of the drill element from the skull and dura surfaces and reducing deflections of the brain.
The drill element may be made of a bio-inert material, such as stainless steel or titanium.
Neurosurgical apparatus may comprise a coordinate positioning apparatus for positioning surgical instruments relative to the skull and a cranial drill system according to the first aspect of the invention.
The coordinate positioning apparatus may be a stereotactic frame or a robot.
The surgical drill element may comprise a profile that forms an opening in the skull having a narrower diameter portion and a wider diameter portion, and an element for penetrating the dura, the element arranged to be a close fit, such as an interference fit, in the narrower diameter portion of the opening. The element may be a further drill element or a spike having a substantially smooth outer surface, without flutes of a drill. In one embodiment, the drilling system comprises a spike for puncturing the dura and a further drill element for drilling into the brain.
The cranial drill system may comprise a guiding element to be located in a hole formed through the skull and a piercing element for piercing the dura, the guiding element having a passageway or channel therein for receiving the piercing element such that the piercing element is movable relative to the guide element to pierce the dura.
In this way, the guide element through its interface with the skull provides a means for positioning the piercing element relative to the hole formed in the skull such that the dura can be pierced at a desired location relative to the hole in the skull.
The guiding element may comprise a dill element for drilling the hole through the skull. Accordingly, the drill is first used to form the hole through the skull and is then used as a guide for guiding the piercing element used to pierce the dura.
Alternatively, the guide element may be a separate element to a drill element used to form the hole. In such an embodiment, the drill element used to drill the hole in the skull is removed from the hole and the separate guide element inserted into the hole and located through its engagement with the hole. To achieve the desired location, the drill element may comprise a profile that forms an opening in the skull having a narrower diameter portion and a wider diameter portion and the guide element may comprise a profile corresponding to the profile of the drill element.
The piercing element may be movable in the passageway or channel from a retracted position in which the piercing element does not project from a distal end of the guide element and an extended position in which the piercing element does extend from a distal end of the guide element. The piercing element may be held within the guide element during location of the guide element in the skull or may be insertable into the passageway or channel after the guide element has been located in the skull. For example, the passageway or channel may extend through the guide element such that the piercing element can be inserted into a proximal end portion of the guide element and moved through the passageway or channel to project from the distal end of the guide element.
The piercing element may be a spike having a substantially smooth outer surface. Alternatively, the piercing element may be a drill element.

Description of the Drawings

Figure 1 shows a cranial drill system not according to the invention;
Figures 2A to 2D shows schematically a method of neurosurgery using the cranial drill system shown in Figure 1;
Figure 3 shows a cranial drill system not according to the invention;
Figures 4A to 4D shows schematically a method of neurosurgery using the cranial drill system shown in Figure 3;
Figure 5 shows a cranial drill system not according to the invention;
Figures 6A to 6D shows schematically a method of neurosurgery using the cranial drill system shown in Figure 5;
Figure 7 shows a cranial drill system according to an embodiment of the invention;
Figures 8A to 8D shows schematically a method of neurosurgery using the cranial drill system shown in Figure 7;
Figure 9 is a schematic view of a cranial drill system according to the invention attached to a stereotactic frame;
Figure 10 is a cross-sectional view of an instrument implanted into the brain;
Figure 11 shows a cranial drill system not according to the invention;
Figures 12A to 12D shows schematically a method of neurosurgery using the cranial drill system shown in Figure 11;
Figure 13 shows a cranial drill system not according to the invention; and
Figures 14A to 14D shows schematically a method of neurosurgery using the cranial drill system shown in Figure 13;

Description of Embodiments

Referring to Figure 1, a cranial drill system 100 is shown comprising a first drill element 102 for drilling into the brain and a second drilling element 104 for drilling into the skull.
The second drill element 104 has a stepped profile with a first, distal portion 106 having a narrower diameter than a second, proximal portion 108. The second portion 108 also has a diameter greater than a diameter of the first drill element 102. The stepped profile of the second drill element 104 matches that of an implantable instrument to be implanted, such as a port and a catheter to be inserted in the brain.
The drill elements 102 and 104 are connected aligned along a common axis to a common shaft 110, which has a mount, in this embodiment a screw thread 111, for attaching the drill system 100 to a surgical drill (501 in Figure 9). Typically, this is achieved by attaching the drill system 100 to a rod 505 that is carried by a stereoguide frame 502 through which drive from the surgical drill 501 can be transmitted. However, the drill system 100 may also be attached to a robot end effector, which, as well as positioning the drill system, may provide rotation for drilling.
In this embodiment, the first drill element 102 extends into a passageway (not shown) through the second drill element 104 and shaft 110 and is fixed in place by a grub screw 112. However, it will be understood that other fixing devices could be used to secure the first drill element 102 in place. Releasing the first drill element 102 from the grub screw 112 allows the length that the first drill element 102 extends from a distal end of the second drill element 104 to be varied as appropriate for the intended target in the brain.
An interface 114 between the second drill element 104 and the shaft 110 provides an abutment that, in use, can be engaged with the surface of the skull to limit the depth to which the drilling system is inserted into the brain.
The first drill element 102 is a twist drill of stainless steel having a point angle at a tip 116 of about 60°. In this embodiment, a single flute 118 is shown. However, it will be understood that the twist drill may comprise multiple flutes, such as two flutes.
The second drill element 104 also comprises one or more flutes 118 for cutting into the skull.
In use, first a target that is to be treated is identified in the brain. This may be achieved by imaging the brain, such as with a CT scan, and identifying from the images 503 a location in the brain to be treated. Based on a measured distance to the target site from a location identified on the skull through which the drill system is to be inserted, a length of the first drill element 102 is set. Referring now to Figures 2A to 2D, the drill system 100 allows drilling of the opening through the skull and into the brain in a continuous (one-step) process. Firstly an opening 150 is drilled into the skull 151 using the first drill element 102 positioned as desired using the stereotactic frame 502 or robot. As the drill system is gradually inserted into the head of the patient, the first drill element 102 contacts the dura 152. At first the dura may be slightly deflected as shown in Figure 2B by the first drill element 102 but the sharp 60° tip 116 soon penetrates the dura. As insertion of the drill system continues with the first drill element 102 entering the brain 155, the second drill element 104 is guided into contact with the skull by virtue of its connection to the first drill element 102 to begin drilling an opening having a larger diameter than that drilled in the skull by the first drill element 102. This is shown in Figure 2C. Drilling is continued until the abutment 114 engages with the surface of the skull. At this point the first drill element 102 should have reached the intended location in the brain 155 based on its set length and the measurements from the images.
The drilling system 100 is removed and a catheter 600 (shown in Figure 10) or other implantable instrument can be inserted onto the opening 154 in the brain 155 for delivering the treatment, such as a drug or electronic stimulus. The instrument may comprise a port 601 or plug at its proximal end having a profile corresponding to the opening 153 formed using the second drill element 104. This port or plug is inserted into the opening 153 on insertion of the instrument into the brain.
Referring now to Figure 3, a cranial drilling system 200 comprises a first drill element 202 for drilling into the brain and a second drilling element 204 for drilling into the skull. The two drilling elements are similar to the drilling elements described with reference to Figure 1 and like reference numerals but in the series 200 have been used to refer to corresponding parts.
In this embodiment, the first drilling element 202 can be inserted from the rear of the body 210 through a passageway 220 and pushed though the passageway so as the tip 216 projects from the distal end of drilling element 204. A stop 222 is provided on a shaft of the first drilling element 202 to contact a proximal end of the body 210, limiting the length of the first drilling element 202 that can project from the distal end of the second drilling element 204. A position of the stop 222 on the first drilling element 202 can be adjusted by loosening grub screw 212 and sliding the stop along the first drilling element 202. Separate mounts 211a and 211b are provided on each of the body 210 and the first drilling element 202 for connecting each to a drill.
Now referring to Figures 4A to 4D, in use, a target is identified from images 503 and the stop 222 moved to a position on the first drilling element 202 such that, when fully inserted into the body 210, the first drilling element projects a desired distance into the brain 155. An opening 153 is then drilled into the skull 151 using the second drilling element (Figures 4A and 4B). The first drilling element 102 is connected to the drill and inserted into the passageway 220 so as to project from the second drilling element 204, which remains attached to the skull 151. The first drilling element 202 is used to puncture the dura 152 and drill into the brain 155 (Figures 14C and 4D), its position guided by the passageway 220 through the second drilling element 204. Drilling continues until stop 222 engages to proximal end of the body 210.
Once the opening 154 into the brain 155 has been formed an instrument, such as catheter 600, is implanted into the opening 154.
In the embodiment shown in Figure 5, the drilling system 300 comprises a first drill element 302 for drilling into the brain and a second drilling element 304 for drilling into the skull. The two drilling elements 302, 304 are similar to the drilling elements described with reference to Figure 1 and 3 and like reference numerals but in the series 300 have been used to refer to corresponding parts. However, unlike the previous drilling systems, the drilling system comprises two instruments that are to be used without a physical connection/engagement.
The first drilling element 302 comprises a distal end having one or more flutes 318 for drilling an opening into the brain 155 and, at a proximal end, scale 322 for measuring the depth that the drill 302 has been inserted into the brain.
The second drilling element 304 comprises at its distal end a pilot drill 324 having a diameter substantially the same as the first drilling element 302.
In use, the second drilling element is first used to drill an opening 153 into the skull 151. This opening 153 includes a pilot hole 153a for guiding later insertion of the first drilling element 302. Once opening 153 has been drilled, the second drilling element is removed and the first drilling element 302 inserted into the opening 153. Contact of the first drilling element 302 with side walls of opening 153a guides the first drilling element 302 to the desired location for penetrating the dura 152 and entering the brain 155. The surgeon can identify whether the target has been reached from the measurement scale 322 on the first drilling element 302.
A further embodiment shown in Figure 7 shows a cranial drilling system 400 comprising a first drill element 402 for drilling into the brain and a second drilling element 404 for drilling into the skull. The two drilling elements 402, 404 are similar to the drilling elements described with reference to Figures 1, 3 and 5 and like reference numerals but in the series 400 have been used to refer to corresponding parts. Like the embodiment shown in Figure 5, the drilling system comprises two instruments that are to be used without a physical connection/engagement.
The first drilling element 402 comprises a distal end having one or more flutes 418 for drilling an opening into the brain 155 and, at a proximal end, scale 422 for measuring the depth that the drill 402 has been inserted into the brain.
The second drilling element 404 comprises at its distal end a guide 426 having a diameter substantially the same as the first drilling element 402.
In use, the first drilling element 402 is first used to drill an opening into the skull 151, to puncture the dura 152 and drill an opening 154 into the brain. The surgeon can identify whether the target has been reached from the measurement scale 422 on the first drilling element 402. The first drilling element 402 is then removed and guide 426 of the second drilling element 404 is inserted into the opening in the skull to locate the second drilling element 404 relative to the opening 154. The second drilling element 404 is then used to drill profiled opening 153, insertion of the drilling element 404 guided by contact of the guide 426 with the side walls of the opening formed previously with the first guide element 402.
Figure 9 shows a typical set-up a neurological apparatus comprising a stereotactic frame 502 used to position a cranial drilling system 500 on a patient's skull 504. A drill 501 is shown connected to the drilling system 500. The drilling system 500 may be any one of the systems described above with reference to Figures 1 to 8.
Figure 10 shows an implantable instrument, in this instance a catheter 600 inserted through a guide tube 602 into the opening formed using the cranial drill system. The catheter 600 can then be used to deliver a drug to a target area 604. The stepped profile formed in the skull by the second drilling element receives the port 601, which has a corresponding profile.
A further cranial drilling system is shown in Figures 11 and 12A to 12D. This embodiment is similar to the embodiment shown in Figure 3 and like reference numerals but in the series 1000 have been used for corresponding features. This embodiment differs from the embodiment shown in Figure 3 in that the first drilling element 202 has been replaced with a spike 1202 for penetrating the dura 1152. The spike 1202 comprises a smooth shaft 1218 without flutes of a drill element and a point 1216. In use, a hole is drilled into the skull using drill element 1204 and then the passageway 1220 is used as a guide to guide the spike 1202 to the desired location above the dura 1152. The spike 1202 is then inserted further to pierce the dura, as shown in Figure 12D. The spike 1202 may be removed before it enters the brain 1155, penetration of the brain achieved using other instruments.
Figure 13 shows an arrangement similar to Figure 5 but with the first drilling element 302 replaced with a spike 1302 for penetrating the dura. The spike 1302 is arranged to be a close fit in the pilot hole drilled using the pilot drill 1324 Such an arrangement may not have some of the benefits derived from drilling into the brain but may benefit from puncturing of the dura with the spike guided by a pilot hole formed in the skull.
Furthermore, in either of the drilling systems shown in Figures 11 and 13, a spike for puncturing the dura may be provided in addition to the first drilling element. With such a system, the spike may be a close fit in the pilot hole and inserted into the pilot hole to puncture the dura. The spike is then removed and the first drill element inserted into the pilot hole to drill into the brain.
As a modification to the embodiment shown in Figure 11, a separate guide element for guiding the spike may be provided. In such an embodiment, a drill element is provided for drilling a particular profile in the skull. The separate guide element comprises a portion having a profile corresponding to the profile of the hole formed using the drill element so that it can be located accurately in the hole through engagement with the hole. The spike is then inserted through the guide element to penetrate the dura.
It will be understood that various modifications and alterations can be made to the described embodiments without departing from the invention as defined herein.

Claims

A kit including
a cranial drill system comprising a first drilling element (402) and a second drilling element (404), the second drilling element (404) for drilling into the skull (151), wherein the second drilling element (404) comprises a guide (426) which during drilling with the second element (404) can extend into and is a close fit in an opening formed by the first drilling element (402); and characterised in that the kit further comprises an implantable instrument (600) for locating within the opening in the skull (151) formed using the cranial drill system such that the implantable instrument (600) is implanted into the brain (155), the cranial drill system arranged to form the opening with a profile corresponding to a profile of the implantable instrument (600).
A kit as claimed in claim 1, wherein the second drilling element (404) comprising a profile that forms the opening (153) in the skull (151) having wider and narrower portions.
A kit as claimed in claim 2, wherein the second drilling element (404) comprises a profile to form the opening (153) in the skull (151) comprising one, two or more stepped transitions between wider and narrower portions.
A kit according to any one of the preceding claims, wherein the guide (426) has a diameter substantially the same as the first drilling element (402).
A kit as claimed in any one of the preceding claims, wherein the second drill element (404) is arranged to form the profile of the opening corresponding to the profile of the implantable instrument (600).
A kit as claimed in claim 5, wherein the implantable instrument (600) comprises a port (601) or plug at a proximal end having the profile corresponding to the opening formed using the second drilling element (404).
A kit as claimed in claim 6, wherein the port (601) or plug is arranged to be inserted into the opening on insertion of the implantable instrument (600) into the brain.
A kit according to claim 6 or claim 7, wherein the second drilling element is arranged to form a stepped profile in the skull (151) for receiving the port (601), which has the corresponding profile.
A kit as claimed in any one of the preceding claims, wherein the implantable instrument comprises a catheter (600).
A kit as claimed in any one of the preceding claims, wherein the implantable instrument comprises an electrode.
A kit as claimed in any one of the preceding claims, wherein the implantable instrument is a guide device.